🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06235151
Active, not recruiting Phase 3

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

NCT06235151 · tracked via the Priya Life Science USA tracker
Sponsor
Curium US LLC
Phase
Phase 3
Started
2024-04-01
Last updated
2026-08-14

Condition(s) studied

Prostate CancerProstate Adenocarcinoma

Investigational drug(s) / intervention(s)

Copper Cu 64 PSMA I&T

Copper Cu 64 PSMA I&T: Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.

Study summary

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients with histologically proven prostate adenocarcinoma. * Planned prostatectomy with pelvic lymph node dissection. * Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions. * Male aged greater than or equal to 18 years. * Able to understand and provide signed written informed consent. Exclusion Criteria: * Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy. * Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration. * Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements. * Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan. * Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration. * Patients with known hypersensitivity to the active substance or any of the excipients of the IP. * Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Urology Centers of Alabama Homewood Alabama
Arkansas Urology Little Rock Arkansas
Providence Medical Foundation Fullerton California
Tower Urology Los Angeles California
VA Greater Los Angeles Healthcare System Los Angeles California
Hoag Memorial Hospital Presbyterian Newport Beach California
University of California, Irvine Orange California
San Francisco VA Medical Center San Francisco California
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
Providence Saint John's Health Center Santa Monica California
Stanford Hospital & Clinics Stanford California
Georgetown University Medical Center Washington D.C. District of Columbia
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center Miami Florida
CIRA Health Miami Florida
Sarasota Memorial Health Care System Sarasota Florida
Florida Urology Partners Tampa Florida
Edward Hines Jr. VA Hospital Hines Illinois
Urology of Indiana, LLC Carmel Indiana
IU Health Neuroscience Center Indianapolis Indiana
University of Iowa Iowa City Iowa
The University of Kansas Hospital Kansas City Kansas
United Theranostics Glen Burnie Maryland
VA Boston Healthcare System Boston Massachusetts
M Health Fairview University of Minnesota Medical Center Minneapolis Minnesota
SSM Health Saint Louis University Hospital St Louis Missouri
John Cochran VA Medical Center St Louis Missouri
Great Plains Health, Diagnostic Imaging North Platte Nebraska
XCancer Omaha Nebraska
United Theranostics Princeton New Jersey
Adaptive Research Inc. Hawthorne New York
Columbia University Medical Center New York New York
James J. Peters VA Medical Center The Bronx New York
UNC Cancer Center Chapel Hill North Carolina
Cleveland Clinic Cleveland Ohio
Dayton Physicians Network / Greater Dayton Cancer Center Kettering Ohio
VA Portland Health Care System Portland Oregon
Hollings Cancer Center Charleston South Carolina
Carolina Urologic Research Center, LLC Myrtle Beach South Carolina
University of Tennessee Medical Center Knoxville Tennessee
Excel Diagnostics and Nuclear Oncology Center Houston Texas

+ 3 more sites — see the full list on the official registry below.

More Curium US LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06235151 on ClinicalTrials.gov ↗ ← All trials in the USA